UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007053 |
|---|---|
| Receipt number | R000006568 |
| Scientific Title | A multicenter study of natural history of pancreatic cystic lesions. |
| Date of disclosure of the study information | 2012/01/15 |
| Last modified on | 2016/01/12 18:37:54 |
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Basic information
Public title
A multicenter study of natural history of pancreatic cystic lesions.
Acronym
N-SPINAL
(Nagoya-Study of Pancreatic cyst and IPMNs Natural history analysis)
Scientific Title
A multicenter study of natural history of pancreatic cystic lesions.
Scientific Title:Acronym
N-SPINAL
(Nagoya-Study of Pancreatic cyst and IPMNs Natural history analysis)
Region
| Japan |
Condition
Condition
Pancreatic cystic lesions
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the natural history of pancreatic cystic lesions.
Basic objectives2
Others
Basic objectives -Others
The occurrence ratio of morphological change and malignant alteration of pancreatic cystic lesions.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Natural history of the pancreatic cystic lesions.
Key secondary outcomes
Incidence of change of image findings.
Malignant alteration ratio of follow up patients.
Resection ratio of follow up patients.
Complication of other organ malignancies.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed as pancreatic cystic lesions at Nagoya university hospital and affiliated hospitals.
2. Pancreatic cystic lesions diagnosed by EUS.
3. 20-80 years of age
4. asymptomatic cases
5. deviated from our surgical indications
6. patients with adequate main organs function
7. patients who provided written informed consent
Key exclusion criteria
1. Patients with symptoms associated with pancreatic lesion.
2. Pregnant and lactating woman
3. Patients with severe drug-induced allergy
4. Difficulty with receiving endoscopic examination.
5. Patients with a history of pancreatic resection.
6. Patients with severe impairment
7. Patients judged as inappropriate by attendant doctor.
8. Patients diagnosed as pancreatic pseudocyst
9. Candidate for surgical treatment.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eizaburo Ohno |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
http://center6.umin.ac.jp/islet/nspinal/
eono@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Aichi Cancer Center Central Hospital, Fujita Health University Hospital, Ogaki City Hospital, etc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋大学医学部附属病院（愛知県） Nagoya University Hospital
愛知県がんセンター中央病院（愛知県）、Aichi Cancer Center Central Hospital
藤田保健衛生大学（愛知県）、 Fujita Health University Hospital
小牧市民病院（愛知県）、 Komaki City Hospital
大垣市民病院（岐阜県）、 Ogaki City Hospital
東海中央病院（岐阜県）、 Toukai Central Hospital
岡崎市民病院（愛知県）、 Okazaki City Hospital
名古屋第一赤十字病院（愛知県）、 Japanese Red Cross Nagoya Daiichi Hospital
大同病院（愛知県）、 Daido Hospital
豊橋市民病院（愛知県）、 Toyohashi City Hospital
一宮市立市民病院（愛知県）、 Ichinomiya City Hospital
江南厚生病院（愛知県）、 Kounankosei Hospital
安城更生病院（愛知県）、 Anjokosei Hospital
豊田厚生病院（愛知県）、 Toyotakosei Hospital
総合上飯田第一病院（愛知県）、 Kamiiida Daiichi General Hospital
八千代病院（愛知県）、 Yachiyo Hospital
公立陶生病院（愛知県） Tosei General Hospital
東海病院（愛知県） Toukai Hospital
山下病院（愛知県） Yamashita Hospital
名鉄病院（愛知県） Meitetsu Hospital
半田市立半田病院（愛知県） Handa Municipal Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter prospective cohort study
Parameters
1) Imaging findings
Clinical diagnosis
Diagnostic modality
Maximum size and features of pancreatic cyst
Maximum size of main pancreatic duct
Maximum size of mural nodules
2) Clinical information and laboratory data
Past history
Family history
Complication of diabetes mellitus
Symptoms
Laboratory data
Pancreatic enzyme
Tumor markers
Management information
Registered date
| 2012 | Year | 01 | Month | 11 | Day |
Last modified on
| 2016 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006568
